Rozetic

Package Leaflet: Information for the Patient

Rozetic, 7.5 mg/g, Gel

Metronidazole

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Rozetic and what is it used for
• 2. Important information before using Rozetic
• 3. How to use Rozetic
• 4. Possible side effects
• 5. How to store Rozetic
• 6. Contents of the pack and other information

1. What is Rozetic and what is it used for

Rozetic gel for cutaneous use contains the active substance metronidazole.
Metronidazole is a nitroimidazole derivative with antibacterial action.
Indications for use:
Local treatment of inflammatory lesions of papules and pustules in rosacea.
Local treatment of skin infections.

2. Important information before using Rozetic

When not to use Rozetic

Warnings and precautions

Before starting treatment with Rozetic, discuss it with your doctor or pharmacist.
Rozetic is intended for cutaneous use only. Do not use it in the eye area or on mucous membranes. If the medicine comes into contact with the eyes, rinse them with plenty of water.
If skin irritation occurs, contact your doctor, who may recommend less frequent use of the medicine or temporary discontinuation of therapy.
During treatment, avoid exposure to sunlight and artificial sources of ultraviolet radiation (e.g., sunlamps).
Metronidazole is a nitroimidazole derivative and should be used with caution in patients with blood diseases. If you have any blood disease or are taking anticoagulant medicines, tell your doctor.
Do not use the medicine for longer than your doctor recommends.

Rozetic and other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
Rozetic is poorly absorbed through the skin after local application, so the risk of interaction with systemic medicines is low.
Do not drink alcohol during and for at least 48 hours after finishing treatment with metronidazole, as a disulfiram-like reaction may occur (flushing, vomiting, tachycardia).
Oral metronidazole may enhance the anticoagulant effect of warfarin and coumarin derivatives, leading to prolonged prothrombin time. It is not known whether locally applied metronidazole affects prothrombin time.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

Rozetic may be used during pregnancy only if your doctor considers it necessary.

Breastfeeding

Do not use the medicine during breastfeeding. Your doctor will decide whether to stop treatment with Rozetic or stop breastfeeding.

Fertility

No data are available.

Driving and using machines

Rozetic has no or negligible influence on the ability to drive and use machines.

Rozetic contains methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), and propylene glycol.

Due to the presence of methyl parahydroxybenzoate and propyl parahydroxybenzoate, the medicine may cause allergic reactions (possible late reactions).
Rozetic contains 30 mg of propylene glycol in 1 g of gel. Due to the presence of propylene glycol, the medicine may cause skin irritation.

3. How to use Rozetic

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Rozetic is intended for cutaneous use only.
Before use, wash the affected areas with a special emulsion for sensitive and delicate facial skin. Apply a thin layer of the medicine to the affected areas on the skin twice a day (morning and evening).
After using Rozetic, patients should use only those cosmetics that do not cause comedones and do not have a drying effect.
Treatment usually lasts from 3 to 4 months. The treatment period should not be extended. However, if there is significant improvement, your doctor may recommend continuing therapy for another 3 or 4 months, depending on the severity of the disease.

Elderly patients

No dose adjustment is necessary in elderly patients.

Use in children

Rozetic is not recommended for use in children due to the lack of data on safety and efficacy.

Overdose

No data are available on overdose in humans.

Missed dose

Use the medicine as soon as possible. If it is almost time for the next dose, do not use a double dose to make up for the missed dose.

Accidental ingestion

Contact your doctor immediately.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported:
Common (less than 1 in 10 patients):
dry skin, redness, itching, skin discomfort (burning, skin pain/stinging), skin irritation, worsening of rosacea symptoms.
Uncommon (less than 1 in 100 patients):
hypoesthesia, tingling and numbness of limbs, metallic taste, nausea.
Unknown (cannot be estimated from the available data):
contact dermatitis, skin exfoliation, facial edema.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Rozetic

Store below 25°C. Do not store in the refrigerator. Do not freeze.
Keep the tube tightly closed.
Keep the medicine out of the sight and reach of children.
Check the expiry date on the medicine.
Shelf life after first opening the tube: 28 days.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Rozetic contains

The active substance is metronidazole.
1 g of gel contains 7.5 mg of metronidazole.
The other ingredients are: carbomer 980, disodium edetate, propylene glycol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), purified water, sodium hydroxide (for pH adjustment).

What Rozetic looks like and contents of the pack

Rozetic is a gel with a uniform consistency, yellow to light yellow in color.
The pack contains an aluminum tube with a membrane seal, internally coated with an epoxy-phenolic lacquer, with a HDPE cap and a piercer, containing 30 g of gel. The tube, together with the patient leaflet, is placed in a cardboard box.

Marketing authorization holder and manufacturer

CHEMA-ELEKTROMET
Cooperative
ul. Przemysłowa 9
35-105 Rzeszów
phone: 17 862 05 90
e-mail: [email protected]

Date of last revision of the leaflet: